Trials / Completed
CompletedNCT03875469
Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes
Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 425 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.
Detailed description
The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Centargo injector (BPI 1000045) | Contrast-enhanced computer tomography conducted with Centargo injector |
| DEVICE | Stellant MP injector | Contrast-enhanced computer tomography conducted with Stellant MP injector |
Timeline
- Start date
- 2019-06-21
- Primary completion
- 2020-03-10
- Completion
- 2020-03-10
- First posted
- 2019-03-14
- Last updated
- 2021-03-03
Locations
2 sites across 2 countries: Australia, Netherlands
Source: ClinicalTrials.gov record NCT03875469. Inclusion in this directory is not an endorsement.